Topics
- Detailed description of HOW TO prepare internal and external audits schedules to include Part 11 audits
- Short and quick overview of the Part 11 regulation
- Execution of the audits
- How to prepare for a specific audit that includes Part 11 regulation
- Training requirements; good practices
- Follow up (difference from other quality audits)
- Warning letters examples
- Commonly asked questions
- The focus is on DIFFERENCE between regular QMS audits in audits when Part 11 is in scope of the audit - from auditors
- What the future holds when it comes to Part 11
- Training
- Regulations
- Execution
- Preparation
- Follow up and other standpoints
Who should Attend
Quality Engineers, Quality Managers, Internal and External Auditors, Small Business Owners, FDA Inspectors, Management Reps and Consultants.
